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A Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in Treatment of Subjects With Moderate-to-Severe Alopecia Areata (AZURE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05205070
Recruitment Status : Recruiting
First Posted : January 24, 2022
Last Update Posted : May 10, 2022
Sponsor:
Information provided by (Responsible Party):
AnaptysBio, Inc.

Study Description
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Brief Summary:
Efficacy and safety of rosnilimab (ANB030) in subjects with moderate-to-severe Alopecia Areata

Condition or disease Intervention/treatment Phase
Alopecia Areata Biological: Rosnilimab Biological: Placebo Phase 2

Detailed Description:
This is a Phase 2, randomized, double-blind, placebo-controlled, parallel-group,multicenter study to evaluate the safety, tolerability, and efficacy of rosnilimab in subjects with alopecia areata (AA).This study also will evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of rosnilimab and evaluate the immunogenicity of rosnilimab in subjects with AA.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded, Placebo controlled, 2:1 ratio of Investigational Product vs Placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Double-blinded design
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rosnilimab (ANB030) in the Treatment of Subjects With Alopecia Areata
Actual Study Start Date : December 22, 2021
Estimated Primary Completion Date : January 19, 2023
Estimated Study Completion Date : March 19, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Rosnilimab (ANB030)
ANB030 biological humanized monoclonal antibody, SC injections every 4 weeks
 Biological: Rosnilimab
humanized monoclonal antibody
Other Name: ANB030
Placebo Comparator: Placebo solution
Placebo solution, SC injections every 4 weeks
 Biological: Placebo
Placebo solution


Outcome Measures
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Primary Outcome Measures :
  1. Change from baseline in Severity of Alopecia Tool (SALT) score at Week 24 [ Time Frame: Week 24 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or nonpregnant, nonlactating female subject aged 18 to 75 years (inclusive) at the time of informed consent.
  • Subjects with a clinical diagnosis of AA defined as having a SALT score ≥ 50 and in which the current episode of hair loss is > 24 weeks (without evidence of spontaneous terminal hair regrowth ≥ 10% within 24 weeks at the time of screening and baseline), but ≤ 8 years (from onset of current episode).

Exclusion Criteria:

  • Concomitant active systemic diseases (except stable thyroid diseases) that may cause hair loss (eg, lupus erythematosus, systemic sclerosis, celiac disease) that could interfere with the Investigators' ability to evaluate the subject's response to therapy.
  • Subject's cause of hair loss is indeterminable and/or in addition to AA they have concomitant causes of alopecia, such as traction alopecia, cicatricial alopecia, lichen planopilaris, frontal fibrosing alopecia, advanced androgenetic alopecia (ie, Ludwig Type III or Norwood-Hamilton Stage ≥ V), telogen effluvium, trichotillomania, or diffuse AA (alopecia areata incognita).
  • Known or suspected congenital or acquired immunodeficiency state, or condition that would compromise the subject's immune status (eg, history of splenectomy).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05205070


Contacts
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Contact: AnaptysBio Inc. (858)362-6295 clinicaltrialinfo@anaptysbio.com

Locations
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United States, Alabama
10-105 Recruiting
Birmingham, Alabama, United States, 35205
United States, California
Site10-103 Recruiting
Encinitas, California, United States, 92024
Site 10-113 Recruiting
Northridge, California, United States, 91324
United States, Illinois
Site 10-115 Recruiting
Chicago, Illinois, United States, 60611
United States, Indiana
10-104 Recruiting
Indianapolis, Indiana, United States, 46250
Site 10-109 Recruiting
Plainfield, Indiana, United States, 46168
United States, Kentucky
Site 10-116 Recruiting
Louisville, Kentucky, United States, 40241
United States, Michigan
Site 10-117 Recruiting
Clarkston, Michigan, United States, 48346
United States, New York
Site 10-111 Recruiting
New York, New York, United States, 10029
United States, North Carolina
Site 10-101 Recruiting
Charlotte, North Carolina, United States, 28277
United States, Ohio
Site 10-102 Recruiting
Bexley, Ohio, United States, 43208
United States, Oklahoma
Site 10-106 Recruiting
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
10-107 Recruiting
Upper Saint Clair, Pennsylvania, United States, 15241
United States, Texas
10-110 Recruiting
Houston, Texas, United States, 77056
Site 10-108 Recruiting
San Antonio, Texas, United States, 78229
United States, Wisconsin
Site 10-114 Recruiting
Kenosha, Wisconsin, United States, 53144
Sponsors and Collaborators
AnaptysBio, Inc.
Investigators
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Study Director: Bruce Randazzo, MD AnaptysBio, Inc.
More Information
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Responsible Party: AnaptysBio, Inc.
ClinicalTrials.gov Identifier: NCT05205070    
Other Study ID Numbers: ANB030-201
First Posted: January 24, 2022    Key Record Dates
Last Update Posted: May 10, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AnaptysBio, Inc.:
PD-1 receptor
Rosnilimab
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
 Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical